510(k) K902481

GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER by Gambro, Inc. — Product Code FJI

K902481 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER". The FDA issued a decision of Substantially Equivalent on July 27, 1990. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Gambro, Inc. has at least 10 other 510(k) clearances on record.